Deulsche

lorschungsgemeinschall
Cerman Pesearch loundalion
d
`~ o~ r
(for Clinical Research Units to be established in 2009 or later)


DlC lorm !.05!e - 8/!0

These guidelines pertain to proposals for Research Units that focus on translational
clinical research with patient-oriented approaches or on understanding disease mecha-
nisms. For Research Units with any other thematic focus, please consult the Guidelines
for Research Units (DFG form 1.05e).
I. Funding Objectives
Clinical Research Units promote the development of networks for disease- or patient-oriented
(translational) clinical research and the long-term implementation of scientific working groups
within clinical institutions. Clinical Research Units allow scientists with outstanding credentials to
collaborate closely on special medium-term research projects whose anticipated findings would
not be achievable under the DFGs Individual Grants Programme or Priority Programmes. Clini-
cal Research Units pursue clinical investigations, integrate clinical findings, and may conduct
clinical pilot studies. Thematically they focus on translational research with patient-oriented ap-
proaches and on understanding disease mechanisms.

A Clinical Research Unit generally centres on coordinated research, conducted according to
subject-appropriate principles. A Clinical Research Unit thus offers a high degree of flexibility in
terms of its structure and objectives.

Clinical Research Units share the following features with other Research Units:

Clinical Research Units are medium-sized research groups set up by the scientists involved.
Each Clinical Research Unit consists of a manageable number of projects and other funding
modules that all deal with the same subject and that can only be worked on as a group in the
proposed manner. To facilitate close collaboration, proposals should generally not encom-
pass more than ten projects.
The main feature of a Clinical Research Unit is collaboration across projects. Clinical Re-
search Units are led by outstanding scientists with international track records and project ex-
perience.
Clinical Research Units bring together the disciplines relevant to research on the topic at
hand.
The topic chosen by a Clinical Research Unit must be current and relevant. Its underlying
concept must be highly innovative and coherent, thus justifying medium-term planning of be-
tween six and, in exceptional cases, eight years.

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The criteria for evaluating scientific excellence that apply under the Individual Grants Pro-
gramme also apply to a Clinical Research Unit and its individual projects.
Clinical Research Units offer ideal conditions for young scientists.

In addition to meeting the above criteria that apply to all Research Units, Clinical Research
Units are also expected to:

improve the situation and quality of clinical research by creating and strengthening research-
oriented structures within university hospitals;
establish or strengthen training structures for clinical research;
enhance the scientific profile of their main location and institution (the review of a Clinical
Research Unit will therefore consider the host universitys commitment to the project);
support the performance-based allocation of resources for clinical research, especially re-
garding the German states subsidies for university hospitals and university medical depart-
ments, and clearly state this both in the draft proposal and the full proposal (What is the cur-
rent status? What are the future goals? Are there separate budgets for teaching and clinical
operations? If so, how will the budgets be separated?);
increase cooperation between clinicians and scientists in the foundational disciplines of
medicine.

One of the researchers submitting the proposal will assume the position of speaker and repre-
sent the Clinical Research Unit in dealings with the DFG and other bodies. The speaker should
be a full-time university teacher.

In addition to the speaker, the Clinical Research Unit will also be headed by a research coordi-
nator. Particular requirements apply to this position with regard to his/her scientific track record,
experience in leading projects (including projects with third-party funding), and integration and
leadership skills. These criteria will be considered during the review process. Once the Clinical
Research Unit is established, the research coordinator assumes the scientific and administrative
leadership of the group. Because the Clinical Research Units main mission is collaborative in-
vestigation, it may be necessary and appropriate in some cases to use funds for an activity
other than the one for which it was specifically granted. The authority to redirect funds in this
manner lies with the speaker and/or research coordinator. In exceptional cases, the Clinical
Research Units speaker may also serve as its research coordinator. The main applicant for the
first funding period is generally the speaker. For the second funding period, the research coor-
dinator serves as the main applicant and the speaker as the co-applicant (see also II.).
II. Types and Duration of Funding
Clinical Research Units consist of researchers who work at university hospitals in close geo-
graphic proximity to each other. Involvement of external researchers working at other locations
is only possible in well-justified exceptional cases. Close collaboration with foundational disci-
plines is strongly encouraged.

The hallmark of a Clinical Research Unit is the establishment or enhancement of research-
oriented structures in university hospitals. The establishment of a research professorship (salary
scale W2 or W3, depending on the persons qualification; plus performance-based bonuses,
depending on publications and third-party funds raised) at the main hospital must therefore be
part of the proposal, unless the holder of an existing research professorship will assume the
scientific leadership of the Clinical Research Unit. Such a research professorship, pre-financed
or co-financed by the DFG, can accelerate new appointments or enable structural measures
such as the establishment of departmental structures or new subject areas. As a prerequisite,
the department of medicine at proposal time must confirm in writing that it will make the re-
search professorship permanent and support it for at least five years after DFG funding expires
(with two research assistants and two technical assistants, plus an appropriate annual allow-

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ance for consumables in the amount of 50,000). The topic of the professorship must coincide
with the mission of the Clinical Research Unit; the research coordinators main focus must be
collaboration within the group. For this reason, the department of medicine must exempt the
research coordinator, upon his or her request, from any clinical obligations.

Because the units research coordinator will generally not yet have been appointed at proposal
time, the formal application to establish a Clinical Research Unit is initially the responsibility of
the speaker, who submits it to the DFG via the universitys medical department. If the research
coordinator has been appointed by the time the renewal proposal is submitted, he/she is the
main applicant for the renewal proposal.

When the DFG approves initial financing, it also declares its intent to continue to fund the pro-
ject for six years (or up to eight years in exceptional cases), contingent on the review of the re-
newal proposal and an evaluation of the project findings.

Clinical Research Units may have a modular structure. Modules are selected according to sub-
ject-specific criteria and may vary between different Clinical Research Units, depending on the
topic chosen, the research areas involved, and the structure-building aspect desired. Modules
include:
1. Research projects
Clinical Research Units typically have fewer than ten projects, which should be proposed
according to the guidelines for the Individual Grants Programme. However, the individual
projects are integrated under the umbrella of the Clinical Research Unit's common re-
search topic. In addition to funding for purely scientific projects, Clinical Research Unit
proposals may also request funding for pilot studies (e.g. specialised outpatient clinics, re-
sources for building and expanding infrastructure for clinical trials, archiving of patient
data).
2. Fixed-term leave
Physicians participating in a Clinical Research Unit can apply to be released from their or-
dinary duties to be able to dedicate themselves to their research projects for a fixed period
of time. Medical assistants are then hired for rotational positions to assume the participat-
ing physicians clinical responsibilities, including highly qualified ones, thus reducing their
workload and enabling them to pursue research projects. Each Clinical Research Unit
must apply for generalised funds for at least one rotational position. The department of
medicine must finance one rotational position in full (or 50% of the budget for rotational
positions if more than one is proposed) from its government subsidies for research and
education. The DFG approves funds to finance one additional rotational position (or 50%
of all rotational positions). Furthermore, the DFG makes available, upon request, flexible
funds in the amount of 60,000 per year to support especially creative structural meas-
ures in hospitals. These rotational positions should be identified as such in the proposal
for the umbrella project; they will also be identified accordingly if funding is approved. For
more details on rotational positions, please consult DFG form 1.12 (available only in Ger-
man).

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3. Promoting young researchers
Clinical Research Units provide an ideal environment for young scientists. Young re-
searchers are therefore able to apply for funding to establish an independent junior re-
search group within the Clinical Research Unit, following the same guidelines as applica-
ble under the Emmy Noether Programme (see DFG form 1.22e). Please note, however,
that funding for a temporary position as principal investigator is not possible, as funding
for project leaders must be provided by the research institution as core support in this
structural measure.

Promising young researchers are to be encouraged to remain in science and academia.
Directly following completion of their doctorates they should therefore be enabled to define
and design their own research topics, which can serve as the basis for an independent
project proposal. For this purpose you may request up to 65,000 in start-up funding per
three-year funding period.

When such funding is requested, a strategy plan for the proposed start-up funding must
be presented, which should especially address the following points:

selection criteria for the individuals to be funded;
type of support the selected individuals will receive in their research with a view to-
ward future proposals and scientific independence;
description of a university environment that can further young researchers careers
during this transitional phase (incl. infrastructure and equipment).
4. Flexible funding to compensate for family leave
To allow research physicians and other scientists who return from parental leave to lead
projects and to submit regular funding proposals for projects within the Clinical Research
Unit, the proposal for the central project may request flexible funds in the amount of
50,000 for a period of one year. These additional funds are meant to enable the Clinical
Research Unit to compensate for any preliminary work or publication shortages due to pa-
rental leave. It is not permitted to redirect these funds to other purposes (e.g. equipment
purchase or project-related travel).
5. Other staff positions
The proposal must include a statement by the department of medicine describing any
plans to systematise and structure doctoral training for medical researchers or to structure
scientific training. Doctoral positions for medical researchers may be proposed in addition
to standard staff funding (grants for research sabbaticals). They must be funded by the
department of medicine following a favourable evaluation.
6. Fellowship programme
Intensive exchange with long-term visiting researchers from other parts of Germany and
abroad, who stay in touch with the group even after they return home, can provide valu-
able insights and make an important contribution to building a visible focus on the re-
search topic. To enable this it is also possible to apply for funding for a fellowship pro-
gramme. Outstanding scientists from other locations may then be awarded fellowships for
extended periods (e.g. one year). They are funded according to the same procedures
used in other DFG programmes for visiting professors (see DFG form 1.161). As a rule,
each fellowship is endowed with sufficient funding to cover the costs incurred by the uni-

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versity.
7. Transfer projects
Transfer projects in Clinical Research Units are strongly encouraged wherever appropri-
ate. Such projects involve direct cooperation with industrial partners. Their goal is to bring
basic research conducted at universities and industrial research closer together. The fol-
lowing conditions apply:

There must be firm evidence of mutual benefit, rather than a one-way transfer of
knowledge.
Basic and/or patient-oriented research must remain the prime focus of the university
project. The usual review criteria apply.
Industrial partners must submit their own proposals for their share of the projects,
which are also assessed by the review panel.

Industrial partners must bear the costs for their own contributions; agreements regarding
the sharing of any profits arising from the research must be established in advance and
may not put the university at any disadvantage (please refer to DFG form 41.026e for a
sample agreement of cooperation between research institutions and commercial enter-
prises). Project findings must be published as appropriate; it is possible to delay publica-
tion subject to prior agreement.
8. Coordination funding and position
The Clinical Research Units speaker (and subsequently its research coordinator) is re-
sponsible for coordinating the group, which also entails public relations and reporting to
the DFG. In addition, the speaker (or research coordinator) is responsible for managing
the units shared funds (for symposiums, visiting researchers, colloquiums, creating and
updating websites, travel, publications, public relations, etc.).

To support coordination tasks, special funding may be requested as part of the central
project in addition to the expenses listed above. Coordination funding allows the unit to
hire a secretary or administrator (provided that his or her coordination tasks have been
adequately defined). Alternatively, the speaker or research coordinator may instead apply
for an allowance of up to 10,000 per year, which may be used to hire assistants or other
clerical support.
III. Proposal Process
Funding proposals
1
must be submitted jointly by all researchers involved in the Clinical Re-
search Unit. They share responsibility for the scientific implementation of the project. One of the
researchers assumes the position of speaker and represents the unit in dealings with the DFG
and third parties. Once the Clinical Research Unit has been established, the person designated
for the research professorship assumes scientific and administrative leadership of the unit.

The proposal process has two stages:
1. Draft proposal
In the first stage of the proposal process, the researchers involved in the Clinical Re-

1
Whether the proposal should be in German or English should be discussed with the appropriate department prior to
submission.

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search Unit submit a draft proposal to the DFG Head Office. The speaker (usually the de-
partment head of the clinical institution that will host the Clinical Research Unit) acts as
the main applicant. The draft proposal should enable the review panel to comparatively
assess the intended research activities in terms of their scientific quality and structural en-
vironment.

The draft proposal should outline the Clinical Research Unit's research programme by ad-
dressing the questions listed below in III.3.a) through i) (on approximately 10 pages). It
should also include a summary (of about 1 to 2 pages) of each of the proposed individual
projects.

To illustrate and enhance your presentation you may refer to your own and others publi-
cations. Make it clear whenever you are referring to other researchers work and explain
your own preparatory work. Please list all cited publications at the end of the section. This
reference list is not considered your list of publications. Any unpublished work must be in-
cluded with the proposal. However, note that reviewers are not required to read any of the
works you cite. Reviews will only be based on the text of the actual proposal.

Please note that the DFG may reject any proposals not in compliance with these rules.

Furthermore, the draft proposal must include information on the project leader (for each
project leader a CV and a list of up to five important publications; plus one project-related
list of publications per individual project; follow the instructions on quantity and structure in
section I.8 of the Supplementary Guidelines and Instructions [DFG form 1.19e]). Please
include an initial rough cost estimate as well. It is especially important to include a written
statement by the department of medicine [cf. III.3.e) and g)]. The draft proposal should not
exceed 25 pages in length, not including CVs (up to two pages each) and publication lists
(ten project-relevant key publications per researcher), which should be submitted in a
separate volume).

a) Draft proposal format
Please submit the draft proposal both as hardcopy (15 copies in DIN A4 format, un-
bound and hole-punched) and as electronic files (e.g. on CD-ROM), preferably in
PDF format (or otherwise in RTF format). Files should not be password protected or
restricted in any other way. The document security settings should allow the docu-
ments to be read, copied and printed.

b) Submission deadline for draft proposals
Deadlines for draft proposals are announced on a regular basis (typically once a
year). This information is also available on our website at
www.dfg.de/en/research_funding/coordinated_programmes/clinical_research_units.

c) Draft proposal review and decision
Submitted draft proposals are assessed by peer reviewers and/or elected review
board members. On the basis of this review, draft proposals are evaluated by way of
comparison by the DFG Senate Commission on Clinical Research. If the evaluation is
favourable, a full proposal (see below) may be submitted, which will usually be as-
sessed on site by a group of reviewers. The funding decision is made by the respon-
sible DFG committee on the basis of the reviews and endorsement by the Senate
Commission on Clinical Research (with involvement of the Review Board for Medi-
cine).
2. Full proposal
The full proposal should follow the format described above in section III.1.a).


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It should not exceed 150 pages in length. CVs and publication lists should be submitted in
a separate volume (as described above in III.1.).

The full proposal should particularly describe the proposed research work, relevant pre-
liminary work, and the type and nature of the cooperation between the applicants, by ad-
dressing the questions listed below in III.3.a) through i) in a format suitable for peer re-
view. Furthermore, the structural aspects mentioned below should be discussed. The de-
scriptions of the individual projects and modules comprising the Clinical Research Unit
should follow the Supplementary Guidelines and Instructions (DFG form 1.19e). Please
note the rules on lists of publications and bibliographies (sections I.8 and II.2 under Pro-
posal Preparation Instructions). Please number all projects or modules consecutively and
include all necessary ethics statements and official permits (see DFG form 1.19e, Sup-
plementary Guidelines and Instructions, II.3.3 through II.3.5). A review panel will evaluate
the proposal, usually at the site of the proposed unit, and issue a recommendation to the
appropriate decision-making bodies within the DFG.

A renewal proposal should describe shared goals that have been accomplished by the
group and any joint events held (seminars, lectures, workshops, symposiums, etc.). It
must also explain why any new projects are being proposed or why any previously funded
projects should be discontinued. A final report must be presented for any projects that are
terminated early. In addition, the renewal proposal must include the responsible state
agencys pledge to provide matching funding for the second funding period, as well as re-
newed guarantees to lift the time limit on the research professorship at the beginning of
the third year of the Clinical Research Units duration, and to provide the necessary core
support after DFG funding expires (see below). After the research professorship has been
made permanent it must be funded by the universitys medical department (from the be-
ginning of the fourth year of DFG funding).
3. Proposal content
The draft proposal and the full proposal should provide a summary of the research pro-
gramme and its intended structure, mention relevant preliminary work, position the project
within a domestic and international context, and describe the type and nature of the coop-
eration between the applicants. In addition it should list the titles of the projects and the
researchers who will handle them. For the draft proposal, a two-page outline should be
provided for each project. Please include CVs and lists of publications for all participating
project leaders, as well as a list of third-party funds received within the last three years.

In addition, the draft as well as the full proposal for the Clinical Research Unit as a
whole should address the following questions:

a) What is the specific relevance/ topicality of the joint research project, and what are the
objectives? Is the collaboration based on an innovative and coherent concept? Can the
stated objectives only be achieved through the proposed cooperation? Do you intend to
involve all of the relevant disciplines necessary to investigate the topic?

b) What key results do you expect in the short to medium term? What long-term results
are anticipated?

c) What qualifications/expertise do the participating researchers and working groups bring
to the project? What preliminary work contributes to the project? If applicable, why is a
working group from another European country or a private business involved, and how
is this of particular importance to the Clinical Research Unit as a whole?

d) What are the expected benefits of collaboration within the group, particularly between
clinicians and basic researchers? How is the collaboration structured?

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e) Do the Clinical Research Units topic, the projects chosen and the participating disci-
plines provide a suitable basis for the department of medicine to further develop its
chosen priorities? Please describe the scientific priorities and the research structure at
the institution(s) involved in the proposal. The draft proposal should include a state-
ment by the department of medicine confirming that the Clinical Research Units topic
fits the departments prioritisation.

f) What are the plans for the appointment of a research coordinator? If a specific person
is being proposed for this leadership role, he/she should be involved in the creation of
the concept. In this case, his/her special expertise should also be documented in a CV
and publication list. In all cases, appointments to research professorships are subject
to the respective states higher education laws. The DFG must also be included in the
appointment process, should the research coordinator be selected through an (interna-
tional) announcement procedure. The DFG is strongly committed to equal opportu-
nities in science and research. We are therefore especially interested in qualified
candidates who can contribute, through their expertise and leadership skills, to
the diversity and excellence of the proposed Clinical Research Unit.

g) What are the modalities by which performance-based government subsidies for re-
search and education are allocated at the host universitys medical department? Are
funds for scientific projects distributed by a research commission? How are overhead
expenses shared within the host university? If approved by the DFG, will the Clinical
Research Unit be guaranteed space and equipment? Will the teams be close to each
other (with the core groups hospital ward and laboratory preferably located in the same
building)? Will space be allocated based on performance?

h) How do you plan to integrate and promote young researchers? Describe any training
programmes and special measures to advance young scientists. Is there an option to
release research clinicians from patient care obligations (rotation programmes)?

i) What are the plans for promoting gender equality within the Clinical Research Unit?
4. Auxiliary support versus core support
The majority of the research projects should be university-based. However, cooperation
with non-university research institutions is also possible.

Expenses must be shared in such a way that core support - especially office/lab space,
equipment, and operating costs - is provided by the university/medical faculty. The extent
and nature of the core support provided by the host institution(s) should demonstrate
commitment to the Clinical Research Unit. Project-specific costs may be funded by the
DFG as auxiliary support, as stipulated in these guidelines and in the Supplementary
Guidelines and Instructions (DFG form 1.19e).
5. Co-financing and budgetary commitment
Funding for Clinical Research Units requires that specific funding modules listed under
section II be financed by the state subsidy through the medical department/university hos-
pital, and subsequently allocated to the unit, together with the core support and the per-
formance-based allocation. Both the draft proposal and the full proposal must include a
written statement by the entities responsible under state law (university hospital, depart-
ment of medicine and/or or state government), vouching that:


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these costs will be assumed and co-financing will be funded from the respective state
governments research and education subsidy to the medical institution;

after three years of DFG support for the proposed research professorship and a posi-
tive interim evaluation, from the fourth year on, the research professorship will be
funded in full by the universitys medical department from the state subsidy for re-
search and education, and will be included in the regular hospital and/or university
budget for at least five years after DFG funding for the Clinical Research Unit expires
(usually after six years), along with the necessary core support to ensure scientific vi-
ability (two research assistants and two technical assistants, plus an appropriate an-
nual allowance for consumables in the amount of 50,000);

at least one rotational position in the Clinical Research Unit (and, if more than one
such position is proposed, 50% of all rotational positions) will be funded from the sub-
sidy for research and education. If one rotational position is approved, the DFG will
fund an additional one. Furthermore, the DFG makes available, upon request, flexible
funds in the amount of 60,000 per year to support especially creative structural
measures in university hospitals.

No co-financing is expected for any projects outside of the department(s) of medicine.

If funding is approved, the DFG pays out its share of the overall budget for the Clinical
Research Unit. Accounting for the unit is expected to identify funds derived from state
government subsidies and how they were used in the project. To simplify accounting, ex-
penditure reports must include both those expenses that were covered by the DFG and
the overall costs of the Clinical Research Unit (divided into payroll and direct project ex-
penses).
6. Final colloquium
If appropriate, a final colloquium may be held after funding for the Clinical Research Unit
concludes (possibly with reviewer participation). If this is planned, such funds should be
requested in the renewal proposal after the first three years of funding. A final colloquium
cannot substitute for a written final report (see guidelines on final reports of Clinical Re-
search Units, available only in German, DFG form 1.052).
IV. Publication of Data on Applicants and Research Projects
The data necessary for processing your grant proposal will be stored and processed electroni-
cally by the DFG. If funding is awarded, your work address (e.g. telephone, fax, e-mail, web-
site), as well as information on the content of your research project (e.g. topic, summary, key-
words, international cooperation), will be published in the DFG's project database GEPRIS
(http://www.dfg.de/gepris) and - in excerpts (grant recipients name, institution and location) - in
the "Programmes and Projects" section of the electronic annual report
(http://www.dfg.de/jahresbericht). If you do not wish this information to be published electroni-
cally, please notify us in writing no later than four weeks after receipt of your award letter.

The DFG expects Clinical Research Units to create and regularly update an appropriate web
presence.

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V. Obligations
By submitting your proposal or draft proposal you agree to:

1. Adhere to the rules of good scientific practice.
2


The general principles of good scientific practice include, among others:
maintaining professional standards,
documenting results,
rigorously questioning all findings, and
attributing honestly any contributions by partners, competitors and predecessors.

In cases of scientific misconduct, the DFG may impose sanctions as listed below. Scien-
tific misconduct is defined as the intentional and grossly negligent statement of falsehoods
in a scientific context, the violation of intellectual property rights or impeding another per-
sons research work. The circumstances of each case will be considered on an individual
basis.

Depending on the nature and severity of the established misconduct, the DFG may im-
pose one or several sanctions. These include:

issuing a written reprimand to those involved;
exclusion from the right to apply for DFG funds for a period of one to eight years, de-
pending on the severity of the scientific misconduct;
revoking funding decisions (complete or partial cancellation of the grant, recalling
granted funds, demanding repayment of funds spent);
demanding that those concerned either retract the discredited publications or correct
the falsified data (in particular by publishing an erratum), or appropriately indicate the
DFGs retraction of funding in the discredited publications;
exclusion from acting as a reviewer or from membership in DFG committees;
denying voting rights and eligibility in elections for DFG statutory bodies and commit-
tees.

By accepting funding, the recipient agrees to:

2. Use the grant exclusively and in a targeted manner to realise the funded project. Use and
accounting of funds must conform to the relevant regulations of the DFG.

3. Report to the DFG on the status of the project and document the use of the grant money
on the dates specified in the award letter.

The DFG expects that the findings of the projects it funds be made available to the public.

2
The rules of good scientific practice are presented in detail in the white paper Proposals for Safeguarding Good
Scientific Practice (published by Wiley-VCH) and in the usage guidelines for research grants, DFG form 2.01 and
2.02 (see DFG website: http://www.dfg.de/en tab Research Funding / Legal Framework Conditions). They are
based on the recommendations of an international commission on self-regulation in science and on a decision by
the DFGs General Assembly, endorsed by the German Rectors Conference, dated 17 J une 1998. According to a
decision made by the General Assembly on 4 J uly 2001, research institutions that have not implemented the rules
of good scientific practice or do not abide by them will not be able to apply for or receive DFG funding as of 1 J uly
2002.
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Poslal address. Deulsche lorschungsgemeinschall, 53!70 8onn, Cermany
Slreel address. Deulsche lorschungsgemeinschall, Kennedyallee 40, 53!75 8onn, Cermany
Tel.. +49 (0) 228 885(!), lax. +49 (0) 228 885-2777
L-mail. poslmaslerdlg.de, lnlernel. www.dlg.de
VI. Declarations
1. Rules of good scientific practice
With regard to the rules of good scientific practice, please confirm the following:

In submitting this proposal for a DFG Priority Programme grant, I agree to adhere to the
rules of good scientific practice.
2. Lists of publications and bibliography
With regard to the guidelines for publication lists and bibliographies listed under section
III.1., please state the following:

In preparing my proposal, I have adhered to the guidelines for publication lists and bibli-
ographies.